Intrathecal Drug Delivery for CHRONIC PAIN

Intrathecal Drug Delivery for

CHRONIC PAIN Evolving Best-Practice Strategies to Maximize Efficacy and Safety This activity is jointly provided by Global Education Group and Integritas Communications.

This activity is supported by an educational grant from Jazz Pharmaceuticals, Inc. An official independent commercially supported satellite symposium held in conjunction with the American Academy of Pain Medicine’s 32nd Annual Meeting and premeeting activities.

There is no registration fee for attending this commercially supported satellite symposium.

Attendees are admitted on a first-come, first-served basis.

CME/MEDICAL COMMUNICATIONS INQUIRIES info@integritasgrp.com integritasgrp.com

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FACULTY

Timothy R. Deer, MD, DABPM President and Chief Executive Officer Center for Pain Relief, Inc. Charleston, West Virginia

Dr. Timothy Deer was born and raised in Chesapeake, West Virginia.

During the last decade, he has originated many ideas that have been incorporated into the mainstream of present day theory and practice of interventional pain management.

Dr. Deer completed his medical school education at West Virginia University, where he was an Alpha Omega Alpha honor student at the top of his class.

After medical school, Dr. Deer attended the University of Virginia School of Medicine, where he trained in Internal Medicine, Anesthesiology, and Pain Medicine.

Over the past 13 years Dr. Deer has held numerous appointments, including that of the Chairman of the American Society of Anesthesiologists’ committee on Pain Medicine. This 42,000–member group represents more pain clinicians than any other organized body. Dr. Deer has also been President of the West Virginia Society of Anesthesiologists, President of the West Virginia Society of Interventional Pain Physicians, and Representative to the Carrier Advisory Committee to Medicare for Ohio and West Virginia.

In addition to those activities, Dr. Deer is on the Board of Directors for the North American Neuromodulation Society. He is also on the editorial committees for the journals Neuromodulation, Pain Medicine, and Pain Physician.

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TARGET AUDIENCE This educational activity is targeted to an audience of pain specialists and other healthcare providers involved in the management of chronic pain patients who are candidates for intrathecal drug delivery

STATEMENT OF NEED/PROGRAM OVERVIEW An estimated 100 million adults in the United States suffer from at least 1 chronically painful condition.1 Complexities in the underlying pathophysiologic mechanisms and clinical manifestations result in a large number of patients for whom conventional management strategies fail to produce adequate pain relief or the desired functional gains.2 For some of these individuals, intrathecal delivery of analgesic medications can be a safe and effective treatment modality.3,4 The US Food and Drug Administration (FDA) has approved 2 analgesics—ziconotide and morphine—as intrathecal medications for patients with severe chronic pain.5,6 Nevertheless, the use of intrathecal therapy for chronic pain is often suboptimal, in part owing to poor patient selection, systemic barriers, and safety concerns (eg, opioid-induced respiratory depression).7 Using a unique case-based educational format, this Interactive Professor™ program will review the latest published evidence and practical guidance on evaluating candidates for intrathecal drug delivery, prescribing FDA-approved intrathecal analgesics, monitoring patients over time, and tailoring therapy based on analgesia, functional outcomes, and treatment-emergent adverse effects.

REFERENCES 1. National Research Council. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Institute of Medicine. Washingon, DC: The National Academies Press; 2011.

2. Gatchel RJ, Peng YB, Peters ML, Fuchs PN, Turk DC. The biopsychosocial approach to chronic pain: scientific advances and future directions. Psychol Bull. 2007;133(4):581-624.

3. Onofrio BM, Yaksh TL, Arnold PG. Continuous low-dose intrathecal morphine administration in the treatment of chronic pain of malignant origin. Mayo Clin Proc. 1981;56(8):516-520.

4. Prager J, Deer T, Levy R, et al. Best practices for intrathecal drug delivery for pain. Neuromodulation.

2014;17(4):354-372.

5. Ver Donck A, Vranken JH, Puylaert M, et al. Intrathecal drug administration in chronic pain syndromes.

Pain Pract. 2014;14(5):461-476.

6. Kim P, Grigsby E, Deer T, et al. Effectiveness and safety of intrathecal ziconotide as the first agent in pump for adult patients with severe chronic pain. Presented at the 22nd Annual Napa Pain Conference; August 27-29, 2015; Napa, CA. 7. Coffey RJ, Owens ML, Broste SK, et al. Mortality associated with implantation and management of intrathecal opioid drug infusion systems to treat noncancer pain. Anesthesiology. 2009;111(4):881-891.

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EDUCATIONAL OBJECTIVES Upon completion of this activity, participants will be better prepared to: • Identify patients with severe chronic pain who are candidates for intrathecal drug delivery • Discuss the clinical profiles, prescribing considerations, and latest clinical trial data for analgesics that have been approved by the FDA for intrathecal drug delivery • Individualize intrathecal treatment regimens for patients with chronic pain based on medical histories, preimplantation trials, and therapeutic responses • Monitor patients receiving intrathecal drug therapy for efficacy, functional gains, and treatment-emergent adverse events

PHYSICIAN ACCREDITATION STATEMENT This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Global Education Group (Global) and Integritas Communications. Global is accredited by the ACCME to provide continuing medical education for physicians.

This CME/CE activity complies with all requirements of the federal Physician Payment Sunshine Act. If a reportable event is associated with this activity, the accredited provider managing the program will provide the appropriate physician data to the Open Payments database.

PHYSICIAN CREDIT DESIGNATION Global Education Group designates this live activity for a maximum of 0.5 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

GLOBAL CONTACT INFORMATION For information about the accreditation of this program, please contact Global at 303-395-1782 or inquire@globaleducationgroup.com.

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INSTRUCTIONS TO RECEIVE CREDIT In order to receive credit for this activity, the participant must submit a completed program evaluation form.

FEE INFORMATION & REFUND/ CANCELLATION POLICY There is no fee for this educational activity.

DISCLOSURE OF CONFLICTS OF INTEREST Global Education Group (Global) requires instructors, planners, managers, and other individuals and their spouses/life partners who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by Global for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations.

The faculty reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity: Timothy R. Deer, MD Consultant – Axonics Modulation Technologies, Inc., Bioness Inc., Ethos Pharmaceuticals, Inc., Flowonix Medical, Inc., Medtronic, Nevro Corp., Nuvectra Corp., Saluda Medical Pty Ltd., SpineThera, Inc., St. Jude Medical, Inc., Vertos Medical Inc.; Grant/Research Support – Bioness Inc., Jazz Pharmaceuticals, Inc., Medtronic, St. Jude Medical, Inc.; Stock Options – Axonics Modulation Technologies, Inc., Bioness Inc., Ethos Pharmaceuticals, Inc., Nuvectra Corp., Saluda Medical Pty Ltd., SpineThera, Inc., Vertos Medical Inc. The planners and managers reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity: Amanda Glazar, PhD Nothing to disclose Andrea Funk

Nothing to disclose

Jim Kappler, PhD

Nothing to disclose

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DISCLOSURE OF UNLABELED USE This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. Global Education Group (Global) and Integritas Communications do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of any organization associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

DISCLAIMER Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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Intrathecal Drug Delivery for CHRONIC PAIN Evolving Best-Practice Strategies to Maximize Efficacy and Safety

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Intrathecal Drug Delivery for CHRONIC PAIN Evolving Best-Practice Strategies to Maximize Efficacy and Safety

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GUIDELINES Polyanalgesic Consensus Conference—2012: Recommendations on Trialing for Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel Deer TR, et al. Neuromodulation. 2012;15(5):420-435. »» http://www.ncbi.nlm.nih.gov/pubmed/22494357

Polyanalgesic Consensus Conference—2012: Recommendations for the Management of Pain

by Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel Deer TR, et al. Neuromodulation. 2012;15(5):436-464. »» http://www.ncbi.nlm.nih.gov/pubmed/22748024

Polyanalgesic Consensus Conference—2012: Recommendations to Reduce Morbidity and Mortality in Intrathecal Drug Delivery in the Treatment of Chronic Pain Deer TR, et al. Neuromodulation. 2012;15(5):467-482. »» http://www.ncbi.nlm.nih.gov/pubmed/22849581

Polyanalgesic Consensus Conference—2012: Consensus on Diagnosis, Detection, and Treatment of Catheter-Tip Granulomas (Inflammatory Masses) Deer TR, et al. Neuromodulation. 2012;15(5):483-495. »» http://www.ncbi.nlm.nih.gov/pubmed/22494332

Best Practices for Intrathecal Drug Delivery for Pain Prager J, et al. Neuromodulation. 2014;17(4):354-372. »» http://onlinelibrary.wiley.com/doi/10.1111/ner.12146/epdf

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SUGGESTED READING Mortality Associated With Implantation and Management of Intrathecal Opioid Drug Infusion Systems to Treat Noncancer Pain Coffey RJ, et al. Anesthesiology. 2009;111(4):881-891. »» http://anesthesiology.pubs.asahq.org/article.aspx?articleid=1932483

Intrathecal Ziconotide and Opioid Combination Therapy for Noncancer Pain: an Observational Study Deer TR, et al. Pain Physician. 2009;12(4):E291-E296. »» http://www.painphysicianjournal.com/2009/july/2009;12;E291-E296.pdf

Factors to Consider in the Choice of Intrathecal Drug in the Treatment of Neuropathic Pain Deer TR, Pope JE. Expert Rev Clin Pharmacol. 2015;8(5):507-510. »» http://www.tandfonline.com/doi/pdf/10.1586/17512433.2015.1060577

Prospective Study of 3-Year Follow-up of Low-Dose Intrathecal Opioids in the Management of Chronic Nonmalignant Pain Hamza M, et al. Pain Med. 2012;13(10):1304-1313. »» http://www.ncbi.nlm.nih.gov/pubmed/22845187

Androgen Deficiency in Long-term Intrathecal Opioid Administration Kim CH, et al. Pain Physician. 2014;17(4):E543-E548. »» http://www.painphysicianjournal.com/current/pdf?article=MjEzOQ%3D%3D&journal=83

Intrathecal Pharmacology Update: Novel Dosing Strategy for Intrathecal Monotherapy Ziconotide on Efficacy and Sustainability Pope JE, Deer TR. Neuromodulation. 2015;18(5):414-420. »» http://onlinelibrary.wiley.com/doi/10.1111/ner.12274/abstract

Intrathecal Therapy: The Burden of Being Positioned as a Salvage Therapy Pope JE, et al. Pain Med. 2015;16(10):2036-2038. »» http://www.neuromodulation.org/Portals/0/Final%20Drug%20Delivery%20for%20Patient.pdf

Practical Considerations and Patient Selection for Intrathecal Drug Delivery in the Management of Chronic Pain Saulino M, et al. J Pain Res. 2014;7:627-638. »» http://www.dovepress.com/practical-considerations-and-patient-selection-for-intrathecaldrug-de-peer-reviewed-article-JPR

Intrathecal Drug Delivery for CHRONIC PAIN Evolving Best-Practice Strategies to Maximize Efficacy and Safety

Safety and Efficacy of Intrathecal Ziconotide in the Management of Severe Chronic Pain Smith HS, Deer TR. Ther Clin Risk Manag. 2009;5(3):521-534. »» http://www.dovepress.com/safety-and-efficacy-of-intrathecal-ziconotide-in-themanagement-of-sev-peer-reviewed-article-TCRM

Long-term Intrathecal Ziconotide for Chronic Pain: an Open-Label Study Webster LR, et al. J Pain Symptom Manage. 2009;37(3):363-372. »» http://www.sciencedirect.com/science/article/pii/S088539240800376X

Clinical Accuracy and Safety Using the SynchroMed II Intrathecal Drug Infusion Pump Wesemann K, et al. Reg Anesth Pain Med. 2014;39(4):341-346. »» http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4218763/pdf/aap-39-341.pdf

Programmable Intrathecal Pumps for the Management of Chronic Pain: Recommendations for Improved Efficiency Wilkes D. J Pain Res. 2014;7:571-577. »» http://www.dovepress.com/programmable-intrathecal-pumps-for-the-management-ofchronic-pain-reco-peer-reviewed-article-JPR

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Intrathecal Drug Delivery for CHRONIC PAIN Evolving Best-Practice Strategies to Maximize Efficacy and Safety

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